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Does PEP Compensate the Reduction of Tidal Volume During One Lung Ventilation? (REVOLU)

Primary Purpose

Lung Neoplasms, Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
One-Lung ventilation
One-Llung ventilation
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Neoplasms focused on measuring Pulmonary disease, Intubation, Intratracheal, Positive-pressure ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age> 18 years
  • Open-chest thoracotomy for pulmonary resection
  • oral consent

Exclusion Criteria:

  • Severe obstructive disease (FEV1 or FEV1 /CV < 70%)
  • Patient who don't tolerate a one-lung ventilation

Sites / Locations

  • Département d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

PaO2/FiO2 after 10 minutes of each strategy

Secondary Outcome Measures

Occurrence of intrinsic PEP.
Haemodynamic side effects: decrease of more than 20% of the arterial systolic blood pressure

Full Information

First Posted
September 24, 2007
Last Updated
January 20, 2010
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00534690
Brief Title
Does PEP Compensate the Reduction of Tidal Volume During One Lung Ventilation?
Acronym
REVOLU
Official Title
Lowering VT and Increasing PEP During One-Lung Ventilation (OLV), Impact on Oxygenation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
During general anesthesia, airway closure and the formation of atelectasis impair oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar recruitment when TV is reduced.
Detailed Description
Approval Status: Approved Approval Number: 2007-06 Board Name: CPP Sud Ouest et Outre-Mer 3 Board Affiliation: French Ministry of Health (DGS) Phone: Email: cpp.soom3@orange.fr No France: Afssaps - French Health Products Safety Agency During general anesthesia, airway closure and the formation of atelectasis impair oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar recruitment when TV is reduced. A recent study reported that mechanical ventilation with large intraoperative TV is associated with an increased risk of post-pneumonectomy respiratory failure. Indeed, large TV during OLV may lead to Ventilator-Induced Lung Injury (VILI) with the creation of alveolar stretch injury and the development of permeability pulmonary edema. The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. Therefore, once TV is reduced, PEP may play a key role in minimizing lung collapse and preventing lung units from repeated opening and collapse phases. Such "protective" ventilatory strategy may be proposed if it does not lead to hypoxemia during exclusion. We, therefore, study the impact on oxygenation, of increasing PEP in order to maintain recruitment, keeping Pplat constant when TV is reduced. We will compare, in each patient without severe pulmonary obstructive disease (FEV1 and FEV1 /CV > 70%), two strategies of ventilation with two different levels of TV and PEP, but keeping the same Pplat : After induction of anesthesia, fiberoptic bronchoscopy confirms the correct position of the tube. Anesthesia is maintained with sevoflurane with a BIS® objective between 45 and 55. Boluses of sufentanyl and cisatracurium are done when clinically necessary. Patients are ventilated in VCV with a ZEUS® respiratory device (Dragger, Germany). Before incision, patients are switched to one-lung ventilation in the lateral position. The tidal volume (TV) is 8 ml/kg of ideal body weight, with a maximal plateau pressure limited to 32 cm H2O. The ventilatory frequency is adjusted in order to maintain end tidal concentrations of carbon dioxide (PetCO2) between 30 to 35 mmHg. 5 cmH2O of positive end expiratory pressure (PEP) is used, and the inspired oxygen fraction is adjusted in order to maintain the pulse oxymetry above 95%. During OLV, if SpO2 decreases to less than 90% with 100% of inspired oxygen fraction, surgery is temporarily stopped to resume two lungs ventilation until SpO2 recover at least 95%. If necessary, a continuous positive airway pressure (CPAP) with 5 cm H2O of oxygen is maintained to provide the non dependent lung. Datas are recorded when the chest is opened. The alveolar pressures and the inspiratory and expiratory flow time curves are monitored. After a period of 15 min, the two strategies are compared in a random order : TV of 8 ml/kg of ideal body weight and a PEP of 5 cmH2O during 10 minutes TV of 5 ml/kg and a PEP level in order to keep the same plateau pressure during 10 minutes. Arterial blood gases are measured after 10 minutes using each strategy and before any vessels are ligated. The occurrence of PEPi is detected on the expiratory flow time curve.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Pulmonary Disease
Keywords
Pulmonary disease, Intubation, Intratracheal, Positive-pressure ventilation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
One-Lung ventilation
Intervention Description
Low Vt, High PEP
Intervention Type
Procedure
Intervention Name(s)
One-Llung ventilation
Intervention Description
High Vt, low PEP
Primary Outcome Measure Information:
Title
PaO2/FiO2 after 10 minutes of each strategy
Time Frame
15 minutes after selective intubation and 10 minutes after the beginning of each ventilation type.
Secondary Outcome Measure Information:
Title
Occurrence of intrinsic PEP.
Time Frame
Peroperative period
Title
Haemodynamic side effects: decrease of more than 20% of the arterial systolic blood pressure
Time Frame
peroperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age> 18 years Open-chest thoracotomy for pulmonary resection oral consent Exclusion Criteria: Severe obstructive disease (FEV1 or FEV1 /CV < 70%) Patient who don't tolerate a one-lung ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadrien ROZE, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul PEREZ, Dr
Organizational Affiliation
University Hospital (USMR), Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
Département d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16809989
Citation
Fernandez-Perez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8. doi: 10.1097/00000542-200607000-00007.
Results Reference
background
PubMed Identifier
16547427
Citation
Gothard J. Lung injury after thoracic surgery and one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):5-10. doi: 10.1097/01.aco.0000192783.40021.c1.
Results Reference
background
PubMed Identifier
16861400
Citation
Slinger P. Pro: low tidal volume is indicated during one-lung ventilation. Anesth Analg. 2006 Aug;103(2):268-70. doi: 10.1213/01.ane.0000223701.24874.c8. No abstract available.
Results Reference
background
PubMed Identifier
16547426
Citation
Senturk M. New concepts of the management of one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):1-4. doi: 10.1097/01.aco.0000192778.17151.2c.
Results Reference
background
PubMed Identifier
17525599
Citation
Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury? Anesthesiology. 2007 Jun;106(6):1226-31. doi: 10.1097/01.anes.0000267607.25011.e8.
Results Reference
background
PubMed Identifier
17065884
Citation
Michelet P, D'Journo XB, Roch A, Doddoli C, Marin V, Papazian L, Decamps I, Bregeon F, Thomas P, Auffray JP. Protective ventilation influences systemic inflammation after esophagectomy: a randomized controlled study. Anesthesiology. 2006 Nov;105(5):911-9. doi: 10.1097/00000542-200611000-00011.
Results Reference
background

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Does PEP Compensate the Reduction of Tidal Volume During One Lung Ventilation?

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